RecruitingNot ApplicableNCT05282654

Real-time Symptom Monitoring Using ePROs to Prevent Adverse Events During Care Transitions


Sponsor

Brigham and Women's Hospital

Enrollment

1,300 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to predict and minimize post-discharge adverse events (AEs) during care transitions through early identification and escalation of patient-reported symptoms to inpatient and ambulatory clinicians by way of predictive algorithms and clinically integrated digital health apps. We will (1) develop and prospectively validate a predictive model of post-discharge AEs for patients with multiple chronic conditions (MCC); (2) combine, adapt, extend, and iteratively refine our EHR-integrated digital health infrastructure in a series of design sessions with patient and clinician participants; (3) conduct a RCT to evaluate the impact of ePRO monitoring on post-discharge AEs for MCC patients discharged from the general medicine service across Brigham Health; and (4) use mixed methods to evaluate barriers and facilitators of implementation and use as we develop a plan for sustainability, scale, and dissemination.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Adult (18 years or older)
  • Hospitalized on the general medicine services at Brigham and Women's Hospital or Brigham and Women's Faulkner Hospital for at least 24 hours
  • Have a discharge status of home, home with services, or facility
  • English-speaking patients or their English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver)
  • Non-English-speaking patients who have an English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver)
  • Two or more chronic conditions: Anxiety, Asthma*, Arthritis (Osteoarthritis, Rheumatoid), Atrial Fibrillation, Cancer*, Cerebral vascular accident, Chronic kidney disease*, Chronic obstructive pulmonary disease (COPD)*, Cirrhosis, Coronary artery disease/Ischemic heart disease, Dementia, Depression, Diabetes mellitus*, End-stage renal disease*, Heart failure*, Hepatitis B, C*, HIV/AIDs, Hyperlipidemia, Hypertension, Inflammatory bowel disease, Osteoporosis, Sickle cell disease, Substance abuse (Alcohol/Opioid)

Exclusion Criteria4

  • Less than 18 years of age
  • Less than two chronic conditions
  • Hospitalized less than 24 hours
  • No identifiable healthcare proxy or next of kin (i.e., a family caregiver)

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Interventions

BEHAVIORALePRO Application

The intervention consists of a patient portal, EHR-integrated web-app to communicate risk of post-discharge adverse events using patient-reported outcome questionnaires, discharge preparation checklist during hospitalization. After discharge, the intervention will provide real-time symptom monitoring using ePROs and facilitate communication with clinicians based on prediction model-informed ePRO score trends exceeding escalation thresholds.


Locations(2)

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT05282654


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